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Home Quality Assurance SOP for Batch Numbering System
SOP for Batch Numbering System
PharmaInfo November 10, 2023
PURPOSE
To ensure that each batch of the intermediate, bulk, or finished product is
identified with a specific number.
SCOPE
All products are produced by PharmaInfo Ltd.
DEFINITION
Batch:
A defined quantity of starting materials, packaging materials, or products
Containers and Closures processed in a single process or series of processes so that it could be
June 15, 2023 expected to be homogeneous. It may sometimes be necessary to divide a Popular Posts
batch into several sub-batches, which are later brought together to form a
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final homogeneous batch. Europe
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Batch Number:
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A distinctive combination of numbers and/or letters that specifically Minimum Re
identifies a batch on the labels, commercial cartons, master cartons, Establish a…
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Standard Operating Procedure describing the details of the batch number. Suitability T
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February 10, 2024 Batch Records:
All documents associated with the manufacture of a batch of the What is Inv
New Drug A
SOP for Handling and intermediate, bulk or finished product. They provide a history of each batch
June 04, 20
Storage of Control… of products and of all circumstances pertinent to the quality of the final
February 10, 2024 product.
Regulatory
for the Drug
SOP for HPLC Analysis &
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Documentation
RESPONSIBILITY
February 10, 2024
Routine responsibility for ensuring that this Procedure is implemented as
New Drug A
when necessary rests with the Production Officers and the Production (NDA) Proce
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SOP for Ope
Flow Chart
Shimadzu H
07,
October
The In-Charge, Quality Assurance Division is responsible for SOP
compliance. Indian Pharmacopoe
PROCEDURE
Production Batch Numbering
It comprises seven digits and includes 07 numerals.
XX/YY/ZZZ
XX: manufacturing Year last two digit
YY: number of Months in Production two-digit
ZZZ: serial number of Batch Production in three-digit
ALSO READ: SOP for Preparation of Certificate of Analysis
An example: Batch number is 2205001 which means 22 the
manufacturing Year last two-digit Product is XX 05 stands for the
number of months in Production two digit is YY (such as May stands for
05) and 001 denotes a serial number of Batch Production three-digit ZZZ
(The Batch number will continue for every different product).
The procedure of Packaging Blister Strip Numbering
It comprises eight-digit it including 01 letters and 07 numerals.
ZZZ/E/YY/XX
ZZZ: serial number of Batch Production in three-digit
E: Expire date
YY: number of Months in Expire two digit
XX: Expire Year last two digit
An example: the Blister Strip number is 001E0522 which means the 001
denotes a serial number of Batch Production in three-digit ZZZ (The
Batch number will continue for every different product) and E stands for
Expire date and 05 stands for the number of Months in Expire two digit YY
(such as May stands for 05) and 22 is stands for Expire Year last two
digits of Product is XX.
Record the batch number issued in a Log Book titled Batch Number Log
Book, mentioning the date of allocation, product name, strength, dosage
form, batch size, and formulation order number.
Ensure that the batch number issued for a particular batch of a
product is used in all relevant documents of the product, label,
commercial cartons, master cartons label, etc.
Identify the product in all processing steps by the same batch number.
ANNEXURE
Nil
REVISION HISTORY
May
Nil
April
ALSO READ: SOP for Analytical Data Review March
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Quality Assurance
OLDER NEWER
SOP for Quality Management Documents Numbering SOP for Quality Assurance Department
System
Posted by PharmaInfo
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